NCT01486836已完成不适用
Evaluation of the Lumax DX ICD and the Linox DX Lead (ICD=Implantable Cardioverter Defibrillator, DX=Extended Diagnostics)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Rate of appropriate atrial sensing
研究概览
简要总结
The objective of this study is to investigate the safety and efficacy of the Lumax DX / Linox DX system.
No hypothesis has been defined.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient meets the indication for ICD therapy
- •LVEF ≥ 30%
- •Patient's compliance with protocol
- •Signed patient informed consent form
排除标准
- •Patient meets one contraindication for ICD therapy
- •Permanent atrial tachyarrhythmia
- •Age < 18 years
- •Cardiac surgery planned within the next 6 months
- •Life expectancy of less than 6 months
- •Limited contractual capability
- •Participating in another clinical study of an investigational cardiac drug or device
结局指标
主要结局
Rate of appropriate atrial sensing
时间窗: 3 months
Rate of successfully terminated tachyarrhythmia episodes
时间窗: 3 months
Serious adverse device effect rate
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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